Status:

COMPLETED

Sensor Validation Study - Quality Assurance

Lead Sponsor:

PMD Solutions

Conditions:

Respiratory Rate

Eligibility:

All Genders

Up to 18 years

Brief Summary

The respiratory rate is an important parameter in clinical medicine. It is defined as the number of breaths per minute. Currently this is measured at the bedside in clinical practice by counting the b...

Eligibility Criteria

Inclusion

  • ≥ 18 Years
  • Have a BMI ≥35
  • For the sub-group analysis at least 5 subjects with a BMI 35-49 and at least 5 BMI \> 50 will be needed
  • Are willing to voluntarily sign a statement of informed consent to participate in this investigation

Exclusion

  • Allergic to medical grade skin adhesive
  • Continuous oral long term steroid use. To be free from oral steroid use this is defined as not using oral steroids in the 4 weeks previous to enrolment
  • Patients under the influence of substance abuse (drug or alcohol) that may interfere with their ability to cooperate and comply with the investigation procedures
  • Any disorder, including cognitive dysfunction, which would affect the ability to accurately complete questionnaires and freely give full informed consent

Key Trial Info

Start Date :

July 28 2017

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 7 2018

Estimated Enrollment :

34 Patients enrolled

Trial Details

Trial ID

NCT03306537

Start Date

July 28 2017

End Date

September 7 2018

Last Update

March 20 2019

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Queen Alexandra Hospital

Portsmouth, United Kingdom, PO6 3LY